Skip to Content

RUPATADINE SUBSTIPHARM 10 MG TABLETS

Active substance(s): RUPATADINE FUMARATE

View full screen / Print PDF » Download PDF ⇩
Transcript
CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – English version
RUPATADINE SUBSTIPHARM 10 mg tablets
Rupatadine

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
 Keep this leaflet. You may need to read it again.
 If you have any further questions, ask your doctor or pharmacist.
 This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
 If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4
What is in this leaflet
1. What RUPATADINE SUBSTIPHARM is and what it is used for
2. What you need to know before you take RUPATADINE SUBSTIPHARM
3. How to take RUPATADINE SUBSTIPHARM
4. Possible side effects
5. How to store RUPATADINE SUBSTIPHARM
6. Contents of the pack and other information
1. WHAT RUPATADINE SUBSTIPHARM IS AND WHAT IT IS USED FOR
Rupatadine, , the active substance in , is an antihistamine.
RUPATADINE SUBSTIPHARM relieves the symptoms of allergic rhinitis such as sneezing, runny
nose, itching in the eyes and nose.
RUPATADINE SUBSTIPHARM is also used to relieve the symptoms associated with urticaria (an
allergic skin rash) such as itching and hives (localised skin redness and swelling).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RUPATADINE SUBSTIPHARM
Do not take RUPATADINE SUBSTIPHARM
 if you are allergic to rupatadine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking this medicine
If you suffer from kidney or liver insufficiency, ask your doctor for advice. The use of RUPATADINE
SUBSTIPHARM 1 0 mg t ablets is at p resent not reco mmended i n patie nts wi th i mpaired kidney or
liver functions.
If you hav e low bl ood levels of p otassium and/or if you have a certain a bnormal pattern to your
heartbeat ( known prolongation of th e QTc interval on t he E CG) which can occu r in some fo rms of
heart disease, ask your doctor for advice.
If you are older than 65, ask your doctor or your pharmacist.
Children and adolescent
RUPATADINE SUBSTIPHARM is not for use in children under 12 years of age.
Other medicines and RUPATADINE SUBSTIPHARM

D 205 – January 2016

Mod 1.3.1.4 page 1

CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – English version

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other
medicines, including medicines obtained without a prescription.
If you are taking RUPATADINE SUBSTIPHARM do not take medicines containing ketoconazole or
erythromycin.
If you are taking central nervous system depressant medicines or statin medicines, ask your doctor for
advice before taking Rupatidine Substipharm.
RUPATADINE SUBSTIPHARM with food and drink
RUPATADINE SUBSTIPHARM should not be taken in combination with grapefruit juice, as
this may increase the level of RUPATADINE SUBSTIPHARM in your body.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Do not take RUPATADINE SUBSTIPHARM during pregnancy and breastfeeding, unless clearly
indicated by your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
At the recommended dosage, RUPATADINE SUBSTIPHARM is not expected to influence your
ability to drive or use machinery. However, when you first start taking RUPATADINE
SUBSTIPHARM you should take care to see how the treatment affects you before driving or using
machines.
RUPATADINE SUBSTIPHARM contains lactose
If you have been told by your doctor that you have intolerance to some sugars, contact your doctor
before taking this medicinal product..
3. HOW TO TAKE RUPATADINE SUBSTIPHARM
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
RUPATADINE SUBSTIPHARM is for adolescents (from 12 years and older) and adults. The usual
dose is one tablet (10 mg of rupatadine) once daily with or without food. Swallow the tablet with a
sufficient quantity of liquid (e. g. one glass of water).
Your doctor will tell you how long your treatment with RUPATADINE SUBSTIPHARM will last.
If you take more RUPATADINE SUBSTIPHARM than you should
If you have accidentally taken a high dose of your medicine, talk to your doctor or pharmacist
immediately.
If you forget to take RUPATADINE SUBSTIPHARM
Take your dose as soon as possible and then continue with your tablets at the usual times. Do not take
a double dose to make up for a forgotten doses.
4. POSSIBLE SIDE EFFECTS

D 205 – January 2016

Mod 1.3.1.4 page 2

CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – English version

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to1 in 10 people) are:
Sleepiness, headache, dizziness, dry mouth, sensation of weakness and fatigue.
Uncommon side effects (may affect up to1 in 100 people) are:
Increased appetite, irritability, difficulty concentrating, nosebleed, nasal dryness, sore throat, cough,
dry throat, rhinitis, nausea, abdominal pain, diarrhoea, indigestion, vomiting, constipation, rash, back
pain, joint pain, muscle pain, thirst, general discomfort, fever, abnormal liver function test and
increased weight.
Rare side effects (may affect up to 1 in 1,000 people): are palpitations, increased heart rate and
hypersensitivity reactions (including anaphylactic reactions, angioedema, and urticarial).
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard.By reporting side effects you can help provide more information on the safety of
this medicine.
5. HOW TO STORE RUPATADINE SUBSTIPHARM
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton.
No special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What RUPATADINE SUBSTIPHARM contains
The active substance is rupatadine. Each tablet contains 10 mg of rupatadine (as fumarate).
The other ingredients are lactose monohydrate, microcrystalline cellulose PH 102, pregelatinized
starch, iron oxide red, iron oxide yellow and magnesium stearate.
RUPATADINE SUBSTIPHARM are round, light salmon coloured tablets packed in unit blister doses
of 20, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
SUBSTIPHARM DEVELOPPEMENT
24 RUE ERLANGER
75016 PARIS
FRANCE

D 205 – January 2016

Mod 1.3.1.4 page 3

CONFIDENTIAL
Module 1.3.1.4

Package Leaflet – English version

This medicinal product is authorised in the Member States of the EEA under the following
names:
Portugal: RUPATADINA SUBSTIPHARM
Italy: RUPATADINE SUBSTIPHARM 10 mg, compresse
Spain: RUPATADINE SUBSTIPHARM 10 mg, comprimidos EFG
Belgium: RUPATADINE SUBSTIPHARM 10 mg, comprimés
The Netherlands: RUPATADINE SUBSTIPHARM 10 mg tabletten
United Kingdom: RUPATADINE SUBSTIPHARM 10 mg tablet
Austria: RUPATADINE SUBSTIPHARM 10 mg Tabletten
This leaflet was last revised in 01/2016.

D 205 – January 2016

Mod 1.3.1.4 page 4

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide